Here is a kind REMINDER to manufacturers operating Class III medical devices in China, your deadline for submitting the 2021 Annual Quality System Self-Inspection Report to China’s provincial level NMPA is January 31st, 2022. Failure to report may possibly lead to the consequences of warning letter, fines, production suspension, even revocation of medical device registration certificate.
The annual report shall contain the following aspects:
Basic overview (date of establishment, size of the enterprise, total number of employees, main business contents)
Changes (personnel, business site, warehouse address, business scope, etc.)
On Dec 1, 2021, NMPA published a notice on the deadline of paying review fee for registration. After official acceptance of domestic Class III, imported Class II and Class III medical device registration, modification, renewal and Class III high-risk medical device clinical trial approval application,
the applicant shall pay the review fee to NMPA within 15 working days. If the payment not made within 15 working days after NMPA acceptance, the application will be considered as the self withdrawal by applicant, and NMPA will terminate its registration procedure.
Once the acceptance of registration application, the registration project will be transferred to NMPA CMDE within 3 working days for them to start review.
On Nov 25, 2021, NMPA published two guidelines on clinical data submission requirement for medical device and IVD registration.
As per BradyKnows experiences, when the applicants choose the clinical trial pathway for China registration or include overseas clinical trial data for submission (either in clinical pathway or CER pathway), the submitted documents include each version of protocol, EC approval, SAR and CSR etc.
But as per the two new guidelines, NMPA encourages the submission of clinical trial data as per Clinical Data Interchange Standards Consortium (CDISC). More source data will be submitted, including original database, analysis database, program code and explanation documents.
Since the implementation of Order 739 Regulations on Supervision and Administration of Medical Devices in June, 2021, China continues to enhance post-market surveillance on medical devices.
NMPA collected the public opinions on Measures For The Administration Of Medical Device Adverse Event Monitoring And Re-evaluation to enhance the adverse event and re-evaluation, timely and effectively control the post-market risk of medical devices, and ensure human health and life safety.
BradyKnows is legal agent for many overseas manufacturers. During the latest experiences for post-market surveillance on medical devices in China, Brady knows how to help your China business in compliance. To enhance post-market surveillance, the works should cover the below key aspects.
Review, evaluate the complaints is adverse event or not, and draft AE report
Draft recall files, fill the recall report and track
Draft adverse event self-inspection report
Review company SOP and evaluate gap when global SOP update, if need, BradyKnows helps update SOP
Improve the quality process
Prepare adverse event self-inspection report
Hold meeting for AE inspection, onsite training and audit for better passing the inspections from local authority
Draft periodic risk evaluate report for current products
Communicate with complaint handling department for adverse event
Understand the regulation update and inspection notice of NMPA
Handle custom issue of medical device in compliance
Chinese label and IFU update of medical device when registration certificate renewed
On Dec 27, 2021, Center for Medical Device Standardization Administration of NMPA published a notice to collect public comments on China Medical Device Catalogue. Any feedback needs to be submitted by January 24, 2022.
Center for Medical Device Standardization Administration is an institution of NMPA to be responsible for standard research and also do medical device classification.
As a fundamental guideline for China registration, Medical Device Catalogue is going to take a secondbatch modification by NMPA. In this modification, some devices for neurological and cardiovascular surgery will be lowered down as Class II medical devices instead of Class III.
In addition, some of the new products are included as the classification examples, which will provide a clearer and more specific instruction during the registration.
It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements.
In order to strengthen the supervision and guidance of medical device product registration and further improve the quality of registration review, according to the Administrative Measures for Registration and Filing of Medical Devices (Order No. 47 of the NMPA), NMPA has organized and formulated relevant technical guidelines.
Below is the summary of NMPA guidelines in December 2021:
Guidelines for technical review of clinical evaluation with predicate for ultrasonic soft tissue dissection hemostasis system
Guidelines for registration review and clinical evaluation with predicate for oral implant surgical navigation and positioning system
Guidelines for registration review of microwave ablation equipment
Guidelines for registration review of endoscopic surgical power tools
Guidelines for registration review of clinical trials for non original CDx companion diagnostic reagents of antitumor drugs
Guidelines for registration review of overseas clinical trial data using in vitro diagnostic reagents
Guidelines for registration review of arthroscopic passive surgical instruments
Guidelines for registration review of disposable ureteral access sheath
Guidelines for orthodontic wire registration review
Guidelines for registration review of disposable minimally invasive fascia closure device
Guidelines for registration review of anesthesia mask products
Guidelines for registration review of non vascular lumen guidewire products
Guidelines for registration review of circumcision stapler
Guidelines for registration review of dental desensitizer
Guidelines for registration review of extracorporeal membrane oxygenation (ECMO) circulation package
Guidelines for registration review of disposable abdominal puncture device
Guidelines for registration review of ossicular prostheses
Guidelines for registration review of artificial ligament
Guidelines for product registration review of funnel chest forming system
Guidelines for registration review of fluorescence immunochromatography analyzer
Guidelines for registration review of network atomizer
Guidelines for registration review of medical diagnostic X-ray equipment including pediatric applications
Guidelines for registration review of ultrasound transcranial Doppler System for blood-flow measurement
Guidelines for registration review of hydrogen peroxide sterilizer
Guidelines for registration review of newborn blue light phototherapy system
Guidelines for registration review of root canal preparation machine
Guidelines for registration review of hematology analyzer
Guidelines for registration review of gait training equipment
Guidelines for registration review of pepsinogen I / II testing reagents
Guidelines for registration review of prothrombin time / activated partial thromboplastin time / thrombin time / fibrinogen test reagent product
Guidelines for registration review of retinol binding protein assay kit (immunoturbidimetry)
Guidelines for registration review of folic acid determination reagents
Guidelines for registration review of anti Mullerian hormone assay reagents
Date: Tuesday, January 11, 2022, 8:00-9:00 AM Pacific Time (US and Canada)
Since the implementation of Order 739 Regulations on Supervision and Administration of Medical Devices in June 2021, China continues to enhance post-market surveillance on medical devices from multiple dimensions. The production, supply, storage, transportation, after-sales maintenance services are inseparable from the quality and safety of medical devices. To strengthen regulatory supervision and ensure quality and safety of medical devices, the “new Regulations” stipulate that the NMPA may conduct extended inspections on business entities and individuals that provide products or services in activities such as medical device development, production, operation, and use. This webinar is to help our audiences better understand and meet the requirements of China’s Good Supply Practices (GSP) and Good Manufacturing Practices (GMP) and be aware of the possible inspections it may receive from NMPA after the product’s market approval.
Here is a kind REMINDER to manufacturers operating Class III medical devices in China, your deadline for submitting the 2021 Annual Quality System Self-Inspection Report to China’s provincial level NMPA is January 31st, 2022. Failure to report may possibly lead to the consequences of warning letter, fines, production suspension, even revocation of medical device registration certificate.
The annual report shall contain the following aspects:
Basic overview (date of establishment, size of the enterprise, total number of employees, main business contents)
Changes (personnel, business site, warehouse address, business scope, etc.)
On Dec 1, 2021, NMPA published a notice on the deadline of paying review fee for registration. After official acceptance of domestic Class III, imported Class II and Class III medical device registration, modification, renewal and Class III high-risk medical device clinical trial approval application,
the applicant shall pay the review fee to NMPA within 15 working days. If the payment not made within 15 working days after NMPA acceptance, the application will be considered as the self withdrawal by applicant, and NMPA will terminate its registration procedure.
Once the acceptance of registration application, the registration project will be transferred to NMPA CMDE within 3 working days for them to start review.
On Nov 25, 2021, NMPA published two guidelines on clinical data submission requirement for medical device and IVD registration.
As per BradyKnows experiences, when the applicants choose the clinical trial pathway for China registration or include overseas clinical trial data for submission (either in clinical pathway or CER pathway), the submitted documents include each version of protocol, EC approval, SAR and CSR etc.
But as per the two new guidelines, NMPA encourages the submission of clinical trial data as per Clinical Data Interchange Standards Consortium (CDISC). More source data will be submitted, including original database, analysis database, program code and explanation documents.
Since the implementation of Order 739 Regulations on Supervision and Administration of Medical Devices in June, 2021, China continues to enhance post-market surveillance on medical devices.
NMPA collected the public opinions on Measures For The Administration Of Medical Device Adverse Event Monitoring And Re-evaluation to enhance the adverse event and re-evaluation, timely and effectively control the post-market risk of medical devices, and ensure human health and life safety.
BradyKnows is legal agent for many overseas manufacturers. During the latest experiences for post-market surveillance on medical devices in China, Brady knows how to help your China business in compliance. To enhance post-market surveillance, the works should cover the below key aspects.
Review, evaluate the complaints is adverse event or not, and draft AE report
Draft recall files, fill the recall report and track
Draft adverse event self-inspection report
Review company SOP and evaluate gap when global SOP update, if need, BradyKnows helps update SOP
Improve the quality process
Prepare adverse event self-inspection report
Hold meeting for AE inspection, onsite training and audit for better passing the inspections from local authority
Draft periodic risk evaluate report for current products
Communicate with complaint handling department for adverse event
Understand the regulation update and inspection notice of NMPA
Handle custom issue of medical device in compliance
Chinese label and IFU update of medical device when registration certificate renewed
On Dec 27, 2021, Center for Medical Device Standardization Administration of NMPA published a notice to collect public comments on China Medical Device Catalogue. Any feedback needs to be submitted by January 24, 2022.
Center for Medical Device Standardization Administration is an institution of NMPA to be responsible for standard research and also do medical device classification.
As a fundamental guideline for China registration, Medical Device Catalogue is going to take a second-batch modification by NMPA. In this modification, some devices for neurological and cardiovascular surgery will be lowered down as Class II medical devices instead of Class III.
In addition, some of the new products are included as the classification examples, which will provide a clearer and more specific instruction during the registration.
It is a great opportunity to have your voices heard by NMPA reviewers and influence them to form a more practical guideline in the end. A thorough and realistic guidance document not only helps NMPA reviewers during their technical review process but also guides manufacturers to satisfy NMPA’s requirements.
In order to strengthen the supervision and guidance of medical device product registration and further improve the quality of registration review, according to the Administrative Measures for Registration and Filing of Medical Devices (Order No. 47 of the NMPA), NMPA has organized and formulated relevant technical guidelines.
Below is the summary of NMPA guidelines in December 2021:
Guidelines for technical review of clinical evaluation with predicate for ultrasonic soft tissue dissection hemostasis system
Guidelines for registration review and clinical evaluation with predicate for oral implant surgical navigation and positioning system
Guidelines for registration review of microwave ablation equipment
Guidelines for registration review of endoscopic surgical power tools
Guidelines for registration review of clinical trials for non original CDx companion diagnostic reagents of antitumor drugs
Guidelines for registration review of overseas clinical trial data using in vitro diagnostic reagents
Guidelines for registration review of arthroscopic passive surgical instruments
Guidelines for registration review of disposable ureteral access sheath
Guidelines for orthodontic wire registration review
Guidelines for registration review of disposable minimally invasive fascia closure device
Guidelines for registration review of anesthesia mask products
Guidelines for registration review of non vascular lumen guidewire products
Guidelines for registration review of circumcision stapler
Guidelines for registration review of dental desensitizer
Guidelines for registration review of extracorporeal membrane oxygenation (ECMO) circulation package
Guidelines for registration review of disposable abdominal puncture device
Guidelines for registration review of ossicular prostheses
Guidelines for registration review of artificial ligament
Guidelines for product registration review of funnel chest forming system
Guidelines for registration review of fluorescence immunochromatography analyzer
Guidelines for registration review of network atomizer
Guidelines for registration review of medical diagnostic X-ray equipment including pediatric applications
Guidelines for registration review of ultrasound transcranial Doppler System for blood-flow measurement
Guidelines for registration review of hydrogen peroxide sterilizer
Guidelines for registration review of newborn blue light phototherapy system
Guidelines for registration review of root canal preparation machine
Guidelines for registration review of hematology analyzer
Guidelines for registration review of gait training equipment
Guidelines for registration review of pepsinogen I / II testing reagents
Guidelines for registration review of prothrombin time / activated partial thromboplastin time / thrombin time / fibrinogen test reagent product
Guidelines for registration review of retinol binding protein assay kit (immunoturbidimetry)
Guidelines for registration review of folic acid determination reagents
Guidelines for registration review of anti Mullerian hormone assay reagents
Date: Tuesday, January 11, 2022, 8:00-9:00 AM Pacific Time (US and Canada)
Since the implementation of Order 739 Regulations on Supervision and Administration of Medical Devices in June 2021, China continues to enhance post-market surveillance on medical devices from multiple dimensions. The production, supply, storage, transportation, after-sales maintenance services are inseparable from the quality and safety of medical devices. To strengthen regulatory supervision and ensure quality and safety of medical devices, the “new Regulations” stipulate that the NMPA may conduct extended inspections on business entities and individuals that provide products or services in activities such as medical device development, production, operation, and use. This webinar is to help our audiences better understand and meet the requirements of China’s Good Supply Practices (GSP) and Good Manufacturing Practices (GMP) and be aware of the possible inspections it may receive from NMPA after the product’s market approval.
Founded in 2007, BradyKnows is a China Market Entry Consulting Firm for both medical device and In Vitro Diagnostic (IVD) companies. In 2021, we established Inspirative Medical in the United States to better multi-culturally communicate with global clients and overcome gaps in R&D/standards/regulations/QMS/PMS between China and other countries.
VISION & MISSION
BradyKnows offers market entry strategy, regulatory and quality consulting, clinical strategy/CER/trials, local testing, legal representation, and commercialization.
We build elite teams for our clients with the full participation of project managers, regulatory/clinical/quality consultants, and technical engineers. The elite team will accompany our clients in the entire product life-cycle and help them overcome challenges and achieve every milestone in China.
